CAMBRIA - Eine offene, randomisierte Phase-III-Studie zur Beurteilung der Wirksamkeit und Sicherheit von Camizestrant (AZD9833, ein selektiver Östrogenrezeptorabbauer der nächsten Generation zum Einnehmen) im Vergleich zu einer endokrinen Standardtherapie (Aromatase-Inhibitor oder Tamoxifen) als zusätzliche Behandlung bei Patientinnen und Patienten mit ER+/HER2- Brustkrebs im Frühstadium und einem mittleren oder hohen Rezidivrisiko, die eine definitive lokoregionäre Therapie ohne nachweisbare Krankheit abgeschlossen haben

Drug: Camizestrant;Drug: Tamoxifen;Drug: Anastrozole;Drug: Letrozole;Drug: Exemestane;Drug: Abemaciclib

Gender: All
Maximum age: 130 Years
Minimum age: 18 Years
Inclusion Criteria:

- Women and Men; =18 years at the time of screening (or per national guidelines)

- Histologically confirmed ER+/HER2- early-stage resected invasive breast cancer with
absence of any evidence of metastatic disease as defined in the protocol.

- Completed adequate (definitive) locoregional therapy (surgery with or without
radiotherapy) for the primary breast tumour(s), with or without (neo)adjuvant
chemotherapy.

- Patients must be randomised within 12 months of definitive breast surgery.

- Patients may have received up to 12 weeks of endocrine therapy prior to
randomisation.

- Eastern Cooperative Oncology Group (ECOG) performance status of = 1

- Adequate organ and bone marrow function

Exclusion Criteria:

- Inoperable locally advanced or metastatic breast cancer

- Pathological complete response following treatment with neoadjuvant therapy

- History of any other cancer (except non-melanoma skin cancer or carcinoma in situ of
the cervix or considered a very low risk of recurrence per investigator judgement)
unless in complete remission with no therapy for a minimum of 5 years from the date
of randomisation

- Any evidence of severe or uncontrolled systemic diseases which, in the
investigator's opinion precludes participation in the study or compliance "

- Known LVEF <50% with heart failure NYHA Grade =2.

- Mean resting QTcF interval > 480 ms at screening

- Concurrent exogenous reproductive hormone therapy or non topical hormonal therapy
for non-cancer-related conditions

- Any concurrent anti-cancer treatment not specified in the protocol with the
exception of bisphosphonates (e.g. zoledronic acid) or RANKL inhibitors ( eg,
denosumab)

- Previous treatment with camizestrant, investigational SERDs/investigational ER
targeting agents, or fulvestrant

- Currently pregnant (confirmed with positive serum pregnancy test) or breastfeeding.

- Patients with known hypersensitivity to active or inactive excipients of
camizestrant or drugs with a similar chemical structure or class to camizestrant. In
pre-/peri-menopausal female and male patients, known hypersensitivity or intolerance
to LHRH agonists that would preclude the patient from receiving any LHRH agonist.